Status:
COMPLETED
Preventive Effects of Bosentan on the Systemic Cardiovascular Consequence of Sleep Apnea
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Actelion
Conditions:
Obstructive Sleep Apnea
Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The study will compared the effects of bosentan, an endothelin receptor antagonist, and nasal continuous positive airway pressure (nCPAP), obstructive sleep apnea current reference treatment, on diast...
Eligibility Criteria
Inclusion
- Documented obstructive sleep apnea
- with untreated mild systemic hypertension
Exclusion
- pregnancy or lactation
- daytime alveolar hypoventilation
- severe arterial hypertension (systolic pressure \> 180 mmHg; diastolic pressure \> 110 mmHg)
- treatment with anti-hypertensive drugs
- cardiovascular disorder other than mild hypertension
- severe daytime sleepiness (score on the EPWORTH sleepiness scale ≥15) or at-risk occupation
- contra-indication to nCPAP treatment
- known allergy to bosentan
- active treatment with a drug whose efficacy is reduced by cytochromes P450, 2C9, 3A4 and2C19 isoenzyme activation
- active treatment with a drug acting on systemic arterial blood pressure or endothelial function
- liver or kidney dysfunction
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00777985
Start Date
December 1 2007
End Date
January 1 2012
Last Update
December 22 2025
Active Locations (1)
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1
CHU de Grenoble
Grenoble, France, 38043